临床及法规事务
  • 临床及法规事务
  • 药物化学
  • 生物部
  • CMC部
  • DMPK
  • Clinical Project Management/临床项目管理

    发布时间:2020年09月24日  


    Senior Manager/Associate Director/Director/Senior Director


    Job Responsibilities:

    1. Plan and deliver the assigned project with high quality, and in accordance of program/company goal, including project timelines, risk assessment, and budget etc

    2. Coordinate project related 3rd party vendor selection (CRO, SMO, central lab etc.) and oversee the vendor performance throughout the study

    3.Manage internal and external clinical development activities with team members involved in the design and conducted of clinical trials

    4. Work closely with CMC function to ensure the timely supply of clinical trial drugs;

    5. Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research

    6.Contributes to relevant study documentation including consent form, protocols, statistical analysis plan, clinical study reports and operational plans

    7.Assists with protocol design and medical issue resolution.

     

    Qualifications:

    1. Bachelor degree or above in life sciences, pharmacy, or medicine related majors;

    2. At least 5 years of clinical research or relevant experience;

    3. Fully understand and be familiar with the application of GCP and ICH guidelines;

    4. Excellent project management skills with sense of responsibility and teamwork spirit;

    5. Good command of English, both in written and spoken, great communication and coordination skills

    6.Demonstrated business ethics and integrity.



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